(129 days)
The BioWaveGO Neuromodulation Pain Therapy Device is indicated for:
- Symptomatic relief of chronic, intractable pain
- Symptomatic relief of acute pain
- As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain
The BioWaveGO Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain the technology of parent devices BioWavePRO. The key difference between the BioWaveGO and the parent device, the BioWaveHOME, is a reduced maximum voltage level, making the device available over-the-counter. The BioWaveGO device has a smaller battery system compared to the BioWaveGO device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain.
The provided text describes the BioWaveGO Neuromodulation Pain Therapy Device, its indications for use, and a comparison with predicate devices to establish substantial equivalence for FDA clearance. However, it does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on sample sizes, ground truth establishment, or expert involvement as requested.
The document primarily focuses on regulatory clearance through substantial equivalence, which compares a new device to existing legally marketed predicate devices, rather than an independent performance study with defined acceptance criteria and statistical analysis.
Therefore, the requested information cannot be fully extracted from the provided text. I will detail what can be inferred or is explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum pain reduction, specific accuracy metrics). Instead, it focuses on functional and electrical safety compliance.
| Acceptance Criteria (Inferred from Performance Testing Summary) | Reported Device Performance (Summary of Testing) |
|---|---|
| Session timer operational only during active treatment | Confirmed |
| Charging only when device not in use | Confirmed |
| Active treatment sessions cannot start during charging | Confirmed |
| Consistent operation across various intensities and load impedances | Ensured |
| Recognition of cable and electrodes before and during session | Ensured |
| Detection of invalid load impedances before and during session | Ensured |
| Resistance to damage/improper software operation from abuse of charger ports | Determined (no damage/improper operation) |
| Inherent protection from excessive battery drain in over-temperature situations | Determined (device protects against abnormal draw) |
| Functional hardware watchdog timers for device reset | Determined (functional) |
| Evaluation of electrical safety | Concluded as compliant (implied by clearance) |
| Compliance with 21 CFR 898 | Yes |
| Compliance with Voluntary Standards | Yes |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The "Performance Testing Summary" outlines a list of tests conducted, but it does not specify the sample size of devices tested or any patient data provenance. The clearance is based on comparison to predicates and engineering/safety testing, not clinical performance data in patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document describes technical performance testing and safety evaluations, not a study that would require expert-established ground truth related to clinical outcomes or image interpretation.
4. Adjudication Method for the Test Set
This information is not provided. As no clinical or interpretive "ground truth" establishment by experts is mentioned, an adjudication method is not applicable to the described engineering and safety tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in this document. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the BioWaveGO device. It is a physical medical device providing electrical stimulation, not an algorithm, and it is intended for human use, either over-the-counter or with a prescription (for its predicate).
7. The Type of Ground Truth Used
The "ground truth" for the tests described appears to be based on engineering specifications, safety standards, and functional requirements of the device. For example, ensuring the session timer is operational only during active treatment means verifying the device's software behaves according to its design specification under various conditions. There is no mention of pathology, expert consensus on clinical findings, or outcomes data being used as ground truth for the technical tests performed.
8. The Sample Size for the Training Set
This information is not provided. Since this is a hardware device cleared based on substantial equivalence and engineering tests, rather than an AI/ML algorithm or a device requiring a clinical efficacy trial with a training set, this concept is not applicable in the context described.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no mention of a training set for an algorithm or a device requiring such.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).